Pevion’s Therapeutic Candida Vaccine Shows Robust Systemic and Mucosal Immunogenicity, While Epidemiological Survey Confirms Excellent Market Potential
BERN, Switzerland, October 11, 2011 /PRNewswire/ –
Pevion Biotech AG today announced latest results from the ongoing
clinical study of its therapeutic Candida vaccine PEV7, showing high levels
of specific antibodies and a 100% mucosal immune response rate. The
announcement further included the results of the largest, international
representative epidemiological survey to date on recurrent vulvovaginal
candidiasis (RVVC), confirming that 7% of adult women suffer from the
disease.
The newly announced data come from the group of volunteers vaccinated
with the intramuscular high dose of PEV7 and showed significantly increased
immunogenicity over the previously vaccinated low-dose group, while
confirming the excellent safety profile customary for virosome-delivered
vaccines. Particularly relevant for the postulated mode-of-action of PEV7
was the strong immune response detected in vaginal and cervical samples. All
volunteers showed a mucosal immune response with consistently high titers
across the group.
“An immune response of this magnitude in the cervicovaginal compartment
is very encouraging with regards to the therapeutic potential of the
vaccine,” stated Jean-Paul Prieels, former Head of Vaccine R&D at
GlaxoSmithKline and recently elected Board Member at Pevion. “After seeing
the first positive immunogenicity data from the low dose group, we defined
criteria on what immunogenicity outcome we would regard as best case for the
high dose. We are delighted that these criteria have been met in full. We
are now following the level of immune response over time and see first
promising signs in terms of mucosal antibody persistence.”
In order to further validate the disease burden and the commercial
potential of PEV7, Pevion mandated the largest, international representative
epidemiological survey on RVVC among 6’000 women, generating robust data on
prevalence, incidence and the age structure of the RVVC patient population.
The study was performed in the US and the five largest European markets by
Ipsos Health, a leader in the field of independent market research.
“The consistency of the Ipsos survey results across countries and with
previous studies is very convincing. RVVC is a common problem throughout the
Western world,” says Prof. Betsy Foxman, a leading RVVC epidemiologist from
the University of Michigan School of Public Health, Ann Arbor, USA. “41% of
women surveyed reported a least one episode of vulvovaginal candidiasis. Of
those, one in five had a 12-month period with 4 or more yeast infections.
Therefore, PEV7 has the potential to address a strong unmet medical need.”
“PEV7 is a first-in-class therapeutic vaccine to address this widespread
and highly debilitating disease,” states Evert Kueppers, CEO of Pevion.
“Based on the positive data from our clinical study, we advance both product
and business development activities for the PEV7 program at full speed.”
About RVVC
Recurrent vulvovaginal candidiasis (RVVC), also known as chronic
recurrent thrush, is a largely unrecognized but highly debilitating
condition, which affects 7% of adult women. It is defined as four or more
acute episodes of symptomatic vulvovaginal candidiasis within a 12 months
period. Clinical symptoms are vulvovaginal inflammation, most often
dominated by severe itching, and other symptoms causing extreme discomfort
and pain. The quality of life of RVVC patients is strongly impacted, both
physically and psychologically. A significant proportion of patients suffer
over many years without perspective for any amelioration or cure from
permanently present painful disease symptoms, impeded activities including
social life and work, partnership problems, and difficulties or
impossibility to talk about it. Over time, accumulating frustration leads to
loss of self esteem, desperation, and in approximately a third of patients,
to depression. Cure rates of RVVC with available antifungal drug therapy
remain disappointing and there is no treatment available to prevent
recurrencies.
About PEV7 therapeutic Candida vaccine
PEV7 is a therapeutic vaccine based on a protein antigen, Sap2, a key
virulence factor of vulvovaginal candidiasis, presented on the surface of
virosomes. Pevion exclusively in-licensed the Sap2 antigen from its academic
partner, the Istituto Superiore di Sanita (ISS) in Rome, Italy.
The ongoing PEV7 Phase I study is designed to assess the safety and
immunogenicity of the therapeutic vaccine candidate in healthy volunteers.
Half of the subjects will receive intramuscular injections, while the other
half will receive capsules, administered intravaginally. In total, the study
will enroll 48 healthy women of childbearing age.
About Virosomes
Virosomes are a regulatory and market-approved vaccine technology that
fulfills carrier and adjuvant functions in one. Essentially, virosomes
represent reconstituted empty influenza virus envelopes, devoid of the
genetic material of the source virus. As such, virosomes do not replicate
and are therefore an ideal combination of carrier plus adjuvant for almost
any given antigen, including peptide or protein derived antigens. The
technology enables the use of poorly immunogenic antigens and thereby
provides access to new indications and markets. Two virosome-based vaccines
(Epaxal(R) and Inflexal(R) V, marketed by Crucell Switzerland AG) are
licensed in over 40 countries, and more than 70 million doses of these
vaccines have been commercially distributed, thereby providing a solid
safety and efficacy track record. Pevion has developed and owns the second
generation of virosomes that have an excellent stability profile through
lyophilization and allow alternative product formulations, such as capsules.
About Pevion Biotech AG
Pevion Biotech AG is a fully independent Swiss vaccine company that
develops innovative vaccines for unmet medical needs based on its clinically
and commercially validated virosome technology. Its proprietary clinical
pipeline includes a first-in-class candidiasis vaccine. A clinical stage
malaria vaccine candidate has been successfully outlicensed, and the
Company’s technology has been licensed for use as an HIV vaccine currently
in human trials. Pevion has in-house development capability and expertise,
including a state-of-the-art and industrially scalable GMP manufacturing
process. Located near Bern, Pevion was established by its founding fathers,
Bachem AG (SWX: BANB) and Berna Biotech (now Crucell, a Johnson & Johnson
subsidiary). To date, Pevion has raised a total of CHF 45 million from its
founders and investors, BZ Bank, Bachem, BB Biotech Ventures and private
investors.
For more information visit http://www.pevion.com
For further information, please contact: Julian Wagner, PhD, Business
Development, Phone: +41-31-550-44-44, info@pevion.com
SOURCE Pevion Biotech AG
